Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068419
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2003-09-10
Brief Title:
Sulindac and Tamoxifen in Treating Patients With Desmoid Tumor
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase II Study of Sulindac and Tamoxifen in Patients With Desmoid Tumors That Are Recurrent or Not Amenable to Standard Therapy
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well giving sulindac together with tamoxifen works in treating patients with desmoid tumor Sulindac may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth Hormone therapy using tamoxifen may fight cancer by blocking the use of estrogen Combining sulindac with tamoxifen may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the safety and efficacy of sulindac and tamoxifen in patients with recurrent desmoid tumor DT and primary DT that is not readily amenable to surgery or radiation therapy
SECONDARY OBJECTIVES
I Determine the tumor response rate in patients treated with this regimen
II Correlate changes in Magnetic Resonance Imaging MRI signal features of the tumor with clinical outcome in patients treated with this regimen
III Correlate pathological studies of cyclooxygenase-2 COX-2 and estrogenprogesterone receptor expression in the tumor with clinical outcome in patients treated with this regimen
IV Collect information about clinical factors that make a tumor unresectable at diagnosis and resectable during the four courses of study treatment
V Determine whether short-term endocrine toxicity is associated with treatment with this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral sulindac and oral tamoxifen twice daily for up to 12 months four 3-month courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 1 additional month of treatment beyond documentation of CR
After completion of study treatment patients are followed for 5 years
I To estimate the safety and efficacy of sulindac and tamoxifen in patients with recurrent desmoid tumor DT and primary DT that is not readily amenable to surgery or radiation therapy
SECONDARY OBJECTIVES
I Determine the tumor response rate in patients treated with this regimen
II Correlate changes in Magnetic Resonance Imaging MRI signal features of the tumor with clinical outcome in patients treated with this regimen
III Correlate pathological studies of cyclooxygenase-2 COX-2 and estrogenprogesterone receptor expression in the tumor with clinical outcome in patients treated with this regimen
IV Collect information about clinical factors that make a tumor unresectable at diagnosis and resectable during the four courses of study treatment
V Determine whether short-term endocrine toxicity is associated with treatment with this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral sulindac and oral tamoxifen twice daily for up to 12 months four 3-month courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR receive 1 additional month of treatment beyond documentation of CR
After completion of study treatment patients are followed for 5 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA098543 | NIH | Childrens Oncology Group | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2009-00424 | REGISTRY | None | None |
| CDR0000322260 | OTHER | None | None |
| COG-ARST0321 | OTHER | None | None |